Research/Clinical Trials Study Manager (REMOTE)
Insight Global3.9
Memphis, TN
Job description

JOB DESCRIPTION

One of our largest clients is seeking a Clinical Trials Study Manager. This resource will be responsible for but not limited to -
Coordinate meetings between working groups (Roche, Global Medicine, client leadership, CRO, client Clinical staff
Trials Operations)
o Schedule meetings and videoconference links as needed
o Plan agendas with PI input
o Take notes, circulate and store for all team members’ access
o Follow up with task owners on action items assigned
o Monthly meeting with Roche
o Weekly meetings with other internal client teams
  • Support development of protocol and related documents (appendices, attachments, etc)
o Assist with management and organization of drafts / drafting process
o Coordinate with subject matter experts for needed information (as per action items)
o Support translations as needed
  • Assist Sr. Coordinator with regulatory submission and review process
o Provide all appropriate/final/clean documents needed to Sr. Coordinator for regulatory
review application
o Assist answering any questions from the application that Sr. Coordinator encounters
o Assist with responses to review committees (coordinate support drafting of new
documents), if applicable
  • Committees: Biostatistics review, Scientific review, IRB
  • Coordinate answers from subject matter experts engaged in this project for
response(s)
  • Primary contact for database build team at our client (CRiSP team)
o Coordinate review and approval of database design specs (DDS)
  • Typically begins when project is submitted to IRB
o Coordinate and participate in database testing phase(s)
  • Communication with CRO (pending contract with CRO)
o Oversight of CRO-assigned tasks
o Coordinating information-sharing between sites, CRO, Roche as needed
  • Shared cloud space
  • Contribute to development of study manual

MINIMUM REQUIREMENTS

  • 5-8+ years of experience around clinical trials (study coordinator, CRA, project management around clinical trials, research study manager, clinical trials manager)
  • Experience running a multi-center trial

DESIRED SKILLS

  • Bilingual in another language
  • Experience with Roche (a sponsor providing study drug)
  • Experience with multi-center trials, pharma trials, (drug company) by name trials, industry sponsored trials, etc.
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Company details

Headquarters

1224 Hammond Drive, Suite 1500, Atlanta, GA 30346

Employee

1001 to 5000

Revenue

$1B to $5B (USD)

Industry

Consulting and Business Services

Company Description
We aren’t just a staffing company. We’re a company that cares for others. It might sound lofty, but it's the idea that gets us up everyday, determined to make it true. Insight Global is a company that people can anchor to in moments of triumph, struggle, and every time in between. Whoever you are and wherever you come from, you matter to us and we have your back. Together, anything is possible.
Company ratings
  • Overall
    3.9
  • Company & Benefits
    3.5 / 5
  • Culture & Values
    3.8 / 5
  • Career Opportunities
    3.3 / 5
  • Work/Life Balance
    3.8 / 5
  • Senior Management
    3.6 / 5
Company reviews
"Great starter job"
Former EmployeeRecruitment Manager
This isn’t something that’s meant to be forever. There’s a reason they hire people straight out of college with no experience…. So they don’t have to pay you what you deserve to be paid. Ultimately, working there was a great decision. It got me wonderful experience and a strong process that they won’t teach you in other places. If your mental health can take it, definitely worth the time put in for the skills you pick up.

"Fun workplace, high earning potential"
Former EmployeeAccount Manager
earning potential at Insight Global is excellent. Work life balance has improved significantly in my time there. Training program for new employees is world class

"Everything sucks "
Current EmployeeHelp Desk Analyst
This job sucks bad. Scheduling is a joke, you’re chained to a headset, internal systems are always breaking, and management is non existent. Stay far away if you value your sanity.

"Mistreated on Work"
Former EmployeeJunior Accountant
Office space was quiet with some mistreatment from longer lasting employees, No one seems to believe what happens in their area and sweep bad behavior under rug but punish those who speak out. Management wasn't great at job and can't handle things on a manager basics. Other than these quiet office space, time to complete task/meet deadlines and lunch breaks are great. You will learn how to use their programs and pivot tables. Emails should be a basic for all at this moment but learn how to send them out at a business level. As a Vet they don't care about people mistreating you and you will lose your job before others if you speak out.
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